BDD With UDCA Therapy After Laparoscopic Cholecystectomy

NCT ID: NCT03578055

Last Updated: 2018-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-24

Study Completion Date

2019-12-31

Brief Summary

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Prospective Study for the Effects of Biphenyl Dimethyl Dicarboxylate and Ursodeoxycolic Acid Therapy on Liver Function and Quality of Life After Laparoscopic Cholecystectomy

Primary endpoint: peak level of postoperative AST (aspartate transaminase) and postoperative ALT (alanine tansaminase)

Secondary endpoint: postoperative GIQLI (Gastrointestinal Quality of Life index) score

Detailed Description

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Because the gallbladder is adjacent to the liver, liver enzymes are often elevated when cholecystitis occurs. BDD and UDCA drugs are known to be effective in preserving liver function. The use of BDD and UDCA drugs in patients with cholecystitis is expected to inhibit elevated liver enzyme levels and to maintain liver function. The aim of this study is to analyze the effects of BDD and UDCA medication on postoperative changes in hepatic enzyme levels and quality of life in patients LFT elevated cholecystitis.

Conditions

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Cholecystitis, Acute Cholecystitis, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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BDD with UDCA

Postoperative BDD with UDCA treatment

Group Type ACTIVE_COMPARATOR

BDD with UDCA

Intervention Type DRUG

Dosage: Udex 1 capsule, 3 times daily Time of administration: 30 minutes after meal Duration of administration: From the day before surgery to 4 weeks after surgery

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Dosage: 1 capsule of placebo, 3 times daily Time of administration: 30 minutes after meal Duration of administration: From the day before surgery to 4 weeks after surgery

Interventions

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BDD with UDCA

Dosage: Udex 1 capsule, 3 times daily Time of administration: 30 minutes after meal Duration of administration: From the day before surgery to 4 weeks after surgery

Intervention Type DRUG

Placebo

Dosage: 1 capsule of placebo, 3 times daily Time of administration: 30 minutes after meal Duration of administration: From the day before surgery to 4 weeks after surgery

Intervention Type DRUG

Other Intervention Names

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UDEX No UDEX

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled for surgery due to chronic cholecystitis and acute cholecystitis

Exclusion Criteria

* Failure to obtain consent
* Under 19 years
* If you have intellectual ability to understand this study
* When performing cholecystectomy with other operations
* Total bilirubin levels\> 2 mg / dl
* If you are enrolled in another clinical trial
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ewha Womans University Mokdong Hospital

OTHER

Sponsor Role lead

Responsible Party

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Huisong Lee

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Huisong Lee, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Ewha Womans University Mokdong Hospital

Locations

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Ewha Womans University Mokdong Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Huisong Lee, M.D., Ph.D.

Role: CONTACT

+82-2-2650-5694

Facility Contacts

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Huisong Lee, M.D., Ph.D.

Role: primary

+82-2-2650-5694

Other Identifiers

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BULQ-LC trial

Identifier Type: -

Identifier Source: org_study_id

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